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New inhaler may ease mouth pain for head and neck cancer patients

NCT ID NCT07327216

Symptom relief Sponsor: Affiliated Hospital of Guangdong Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a drug called Sapylin, given through an inhaler, can prevent or reduce painful mouth sores caused by chemotherapy and radiation for nasopharyngeal cancer. About 180 adults with advanced cancer will be randomly assigned to receive either Sapylin or the standard treatment dexamethasone. The goal is to find a safer, more effective way to manage this common side effect and help patients complete their cancer therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Inclusion Criteria: * Stage III-IVa NPC (AJCC 8th edition) diagnosed via pathology in a tertiary hospital; * No previous radiotherapy, chemotherapy, surgery, immunization, or targeted therapy; * Karnofsky Performance Status score ≥80; * Intact and normal oral mucosa before treatment; * Age 18-75 years; * Voluntary participation and provision of informed consent in person; * Routine blood examination: white blood cell count ≥4.0×109/L, hemoglobin ≥100g/L, neutrophil count ≥1.5×10\^9/L, and platelet count ≥100×10\^9/L; * Biochemical examination: total bilirubin ≤1.5×the upper limit of the normal range (ULN), alanine aminotransferase and aspartate aminotransferase ≤2×ULN, and estimated glomerular filtration rate ≥60 mL/min. 2. Exclusion Criteria: * With other malignant tumors in the past or present and/or distant metastasis during treatment; * Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy; * With a history of asthma, rash, urticaria, and other allergic diseases; * With a history of autoimmune diseases, connective tissue diseases, and diabetes mellitus that significantly affect the healing of the oral mucosa; * With concomitant diseases, such as heart disease, kidney disease, and acute infectious diseases, which are judged by the investigator to seriously endanger the safety of patients or affect the completion of the study; * Who are breastfeeding, pregnant, or planning to become pregnant during the study; * With known allergies to the therapeutic agents and penicillin used in the trial; * Mental or nervous system diseases or poor compliance.

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasopharyngeal carcinoma (NPC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Guangdong Medical University

    RECRUITING

    Zhanjiang, Guangdong, China

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